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Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351363
First Posted: May 10, 2011
Last Update Posted: May 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Fife
  Purpose

Following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain.

This study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.


Condition Intervention
Arthroscopic Shoulder Surgery Pain Threshold Device: Electrical pain threshold measurement Device: Measurement of electrical pain threshold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY

Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Post operative pain level [ Time Frame: 4 days ]
    Post operative pain level recorded on a VAS (0-10) at rest and movement for the first four days pots shoulder surgery. This information will be correlated with the preoperative pain threshold of patients taken with the Pain matcher machine.


Enrollment: 43
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical pain threshold measrement patients Device: Electrical pain threshold measurement
Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
Other Name: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Device: Measurement of electrical pain threshold
Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
Other Name: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)

Detailed Description:
Patients presenting for elective (day case) arthroscopic shoulder surgery for either Arthroscopic Subacromial Decompression (ASD Group) or Rotator Cuff Repair (RCR Group) are recruited. Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. The patients will then have a standard anaesthetic administered with TIVA (propofol/remifentanil) and either a subacromial injection (ASD Group) or interscalene block (RCR Group). Four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)

Exclusion Criteria:

  • Unable to give informed consent
  • Allergy to remifentanil, propofol or levobupivacaine.
  • Absence of contralateral arm (thumb/fingers)
  • Documented sensory abnormality (e.g. peripheral neuropathy)
  • Those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery).
  • Psychiatric disease (documented history in Hospital notes or GP referral summary)
  • Drug or alcohol misuse (suspicion of or documented)
  • No telephone or unable to communicate in English (no interpreter service available)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351363


Locations
United Kingdom
Victoria Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Sponsors and Collaborators
NHS Fife
Investigators
Principal Investigator: Anthony Davis, MBChB NHS Fife
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doctor Anthony Davis, NHS Fife
ClinicalTrials.gov Identifier: NCT01351363     History of Changes
Other Study ID Numbers: SHLDR1
First Submitted: May 9, 2011
First Posted: May 10, 2011
Last Update Posted: May 10, 2011
Last Verified: May 2011

Keywords provided by NHS Fife:
Arthroscopic shoulder surgery
Pain threshold

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms